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Comment: Time to go public on clinical trials

12 October 1991

Britain’s obsession with secrecy, and the American predeliction for
litigation, have combined to prevent British doctors and patients finding
out why the sleeping pill, triazolam, best known as Halcion, is now forbidden
to them. The Committee on Safety of Medicines announced last week that it
was ordering the withdrawal of the drug.

The decision leaves many questions unanswered (see This Week). Triazolam
has been on the market for 13 years, and more than 2 million prescriptions
are written for it every year. Yet only now has the CSM agreed that its
psychiatric side effects are serious enough to warrant a ban.

Until last week, the pharmaceutical industry considered triazolam the
‘gold standard’ against which all newcomers were tested. Patients will now
want to know why their sleeping tablets are to be changed – and doctors
must be in a position to explain.

Part of the committee’s reason appears to stem from trials of the drug,
which date back to 1972, and remain confidential. These trials came to light
in a legal action against Upjohn, which makes Halcion, by Ilo Grundberg
from Utah. Grundberg shot her mother but claimed she had no memory of the
incident because she was under the influence of Halcion at the time. She
was never prosecuted, and Upjohn settled out of court without admitting
liability.

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Ian Oswald, emeritus professor of psychiatry at Edinburgh University
– who has long believed triazolam should be withdrawn from the market –
was to have given evidence on behalf of Grundberg. He is privvy to some
of the early trials Upjohn performed with the drug, and considers them to
be of public concern. However he is prevented from speaking about his fears
by a US court order, requested by Upjohn.

The CSM is prevented under the Medicines Act 1968 from saying more about
its decision. Data sent by drug companies to the committee are confidential,
for primarily commercial reasons. It is obvious why a company would want
to keep secret its method for synthesizing its drugs. But it is less clear
why clinical results should be kept secret.

Once a drug is approved for use, all clinical and scientific data should,
with adequate safeguards on intellecutal property, be made public – whatever
the qualms of the drug companies. Is it not time that the Medicines Act
was changed to make information publicly available in matters of such obvious
public importance?